Implantable article and method

ABSTRACT

An implantable article and method are disclosed for treating pelvic floor disorders such as vaginal vault prolase. A surgical kit useful for performing a surgical procedure such as a sacral colpopexy is also described.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. Ser. No.10/431,719, filed May 8, 2003, now U.S. Pat. No. 6,884,212, which is adivisional of application Ser. No. 09/939,282, filed Aug. 24, 2001, nowU.S. Pat. No. 6,592,515, issued Jul. 15, 2003, which claims priority toU.S. Provisional Patent Application No. 60/230,647, filed Sep. 7, 2000and U.S. Provisional Application Ser. No. 60/269,828, filed Feb. 20,2001, the entire contents of each of which are fully incorporated hereinby reference.

BACKGROUND

There are a variety of materials approved by regulatory agencies forimplantation into the human body. Examples of such materials includeTrelex Polypropylene Mesh, available from Boston Scientific ofMinneapolis Minn.), Marlex Mesh (polypropylene suture material,available from Phillips Sumika Polypropylene Co., Houston, Tex.),Prolene™ Mesh (available from Ethicon, Inc. of Sommerville, N.J.),Mersilene material (polyester fibermesh) and Gore-Tex fabric (expandedpolytetrafluoroethylene laminated fabric, available from W. L. Gore andAssociates Inc., Elkton, Md.). Many of these materials are integratedinto devices that are implanted in the body. As a commercial example,silicone covered polyester is used as a component of an ArtificialUrinary Sphincter model # 800, available from American Medical Systems,Inc. of Minnetonka, Minn.

Pelvic floor disorders include cystocele, rectocele, enterocele anduterine and vaginal vault prolapse. These disorders typically resultfrom weakness or damage to normal pelvic support systems. The mostcommon etiologies include childbearing, removal of the uterus,connective tissue defects, prolonged heavy physical labor andpostmenopausal atrophy.

Vaginal vault prolapse is the distension of the vaginal apex outside ofthe vagina. An enterocele is a vaginal hernia in which the peritonealsac containing a portion of the small bowel extends into therectovaginal space. Vaginal vault prolapse and enterocele representchallenging forms of pelvic disorders for surgeons.

Vaginal vault prolapse is often associated with a rectocele, cystoceleor enterocele. It is known to repair vaginal vault prolapse by suturingto the supraspinous ligament or to attach the vaginal vault through meshor fascia to the sacrum. Many patients suffering from vaginal vaultprolapse also require a surgical procedure to correct stress urinaryincontinence that is either symptomatic or latent.

Sling procedures are surgical methods that place a sling to stabilize orsupport the bladder neck or urethra. They are typically used to treatincontinence. There are a variety of different sling procedures. Slingsused for pubovaginal procedures differ in the type of material andanchoring methods. In some cases, the sling is placed under the bladderneck and secured via suspension sutures to a point of attachment (e.g.bone) through an abdominal and/or vaginal incision. Examples of slingprocedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515;5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.

A sacral colpopexy is a procedure for providing vaginal vaultsuspension. It may be performed through an abdominal incision, a vaginalincision or laparoscopically. Complications include mesh infection, mesherosion, bowel obstruction, ileus, and bleeding from the presacralvenous complex. Typically, this procedure is accompanied by an abdominalenterocele repair and cul-de-sac obliteration.

A sacral colpopexy entails suspension of the vaginal cuff to the sacrumwith fascia or synthetic mesh. The synthetic mesh is typically carefullycustomized or assembled into a special shape by the surgeon. A surgeonmanually cuts a sheet of the mesh and stitches elements of the mesh toform the special shape. The literature reports surgeons suturing meshmaterial into various T-shaped articles. See Winters et al., AbdominalSacral Colpopexy and Abdominal Enterocele Repair in the Management ofVaginal Vault Prolapse, Urology 56 (Suppl 6A) (2000): 55-63; and Paraisoet al, Laparoscopic Surgery for Enterocele, Vaginal Apex Prolapse andRectocele, Int Urogynecol J (1999), 10:223-229.

Suturing mesh material into T-shaped articles is a meticulous,time-consuming task. Valuable surgeon time is consumed during this task.It is reported that the average time for colpopexy and enterocele repairalone is at least 20 minutes and more likely approximately ninetyminutes. It is reported that 72% of patients with vault prolapse had acombination of other pelvic floor defects. See Richter K: MassiveEversion of the Vagina: Pathogenesis, Diagnosis and Therapy of the TrueProlapse of the Vaginal Stump, Clin. Obstet Gynecol 25:897-912 (1982).If surgical correction of cystocele, rectocele or stress incontinence isperformed in the presence of untreated vaginal vault prolapse, an earlyrecurrence of prolapse is extremely likely. When it is considered thatit is often necessary to correct multiple pelvic floor disorderssimultaneously, the time factor for surgeons is particularlychallenging. See, Diana et al., Treatment of Vaginal Vault Prolapse withAbdominal Sacral Colpopexy Using Prolene Mesh, American Journal ofSurgery, Vol. 179, (February 2000), Pps. 126-128.

U.S. Pat. No. 6,264,702 describes a prosthesis for preventingpost-surgical adhesions. The prosthesis may be used in visceral,parietal or neurological surgery, particularly hernia repair.

U.S. Pat. No. 4,655,221 discloses a surgical repair mesh and a method ofusing a surgical repair mesh.

PCT Publication No. WO 00/64370 (Gaston) describes a device for treatinga prolapse by vaginal suspension. The device comprises an elongate,flexible, pierced material, a suture connected to the material and asuture needle joined to the suture. The device is long enough to enableposterior suspension of the vagina at the promontory (i.e. the frontupper part of the sacrum). The other end of the device includes a distalportion having a width such that it can cover at least a large part ofthe posterior part of the vagina, a rounded cut-out with dimensions thatenable it to be engaged around the base of the vagina on at least alarge part of the lower half of the wall of the vagina. The suture isconnected to the article so that it is offset sidewise in relation tothe cut-out.

U.S. Pat. No. 6,162,962 discloses an areal implant, in particular forabdominal wall closure. The implantable article may be constructed froma knitted fabric comprising a non-resorbable or slowly resorbablematerial.

U.S. Pat. No. 4,769,038 discloses prostheses for repair of inguinal andfemoral hernias. FIG. 1 of that patent illustrates a three panelinguinal prosthesis.

U.S. Pat. Nos. 5,195,542 and 5,441,508 (Gazielly et al.) disclose arotator cuff reinforcement strip for surgical implantation to a shoulderof a person. In one embodiment, the strip has a rear heel for fixationto at least one of a trochiter and a tendinous mass of the patient'srotator cuff. The strip may have a linear extension or divergent legsfrom the heel defining opposite ends for fixation to respectivetendon(s) of the rotator cuff. In one embodiment, the strip is describedas defining a Y-shape. The device may consist of a single layer ofbraided polypropylene material.

PCT Publication No. WO 00/27304 (ORY et al.) discloses a suspensiondevice for treating prolapse and urinary incontinence. The devicecomprises at least one filiform suspension cord with limited elasticityand at least two anchoring parts linked to the ends of the cord.

BRIEF SUMMARY

The present invention is directed to a preassembled implantable articlesuitable for a variety of surgical procedures, preferably urologicalprocedures and more particularly to those directed to pelvic floordisorders. The preassembled implantable article reduces the challengefaced by the surgeon by eliminating the need to meticulously create acustomized implantable article for such surgical procedures.

In one aspect, the present invention comprises an implantable surgicalarticle comprising a thin, substantially flat major strip havingproximal and distal ends, and a length and a width along first andsecond orthogonal axes, and a thin, substantially flat minor striphaving a length less than that of the major strip, and a pair of ends.The minor strip is bonded to the major strip along an end of the minorportion such that a substantial portion of the minor strip can extendalong an axis that is perpendicular to both the first and second axes.The location of the bond is preferably selected such that a portion ofthe major strip near its distal end and the minor strip may be suturedto a vaginal cuff of a patient. The distance between the proximal end ofthe major strip and the bond is at least sufficient to extend from thepatient's sacrum to the vaginal cuff.

Preferably, the straight edges of the major and minor strips aresubstantially aligned to provide a surgical article with a substantiallyconstant width. Also preferably, the minor strip is bonded to the majorstrip along substantially all of the end of the minor strip. Morepreferably, the distal ends of the major and minor strips aresubstantially aligned.

Alternatively, the invention may be viewed as an implantable surgicalarticle for treating a pelvic floor disorder, such as for a sacralcolpopexy procedure. The article comprises a base portion, a headportion comprising two tissue engagement portions extending from thebase portion, and separation force distribution means for attaching atleast one of the tissue engagement portions to the base portion in afashion that distributes a force that would tend to separate a tissueengagement portion from the base portion across an area greater thanthat occupied by a suture.

The separation force distribution means may comprise a variety of means,such as a bonding composition (e.g. an elastomeric material), a tissueadhesive, a tissue sealant, an ultrasonic weld, or a mechanical fastener(e.g. a polymeric clip).

The article may have other optional features. For example, the articlemay include means for adjusting the tension of the implantable article.The means may include wheels rotatably associated with a clip that alsoattaches the base portion of the implant to the tissue engagementportions. Optionally, the tension adjustment means may comprise a meansfor indexing the wheel between a plurality of positions. In oneembodiment, the tension adjustment means may comprises a ratchet wheel,pawl and spring assembly.

The surgical article preferably comprises a backing and a coating. Inone embodiment, the backing comprises a polymeric material or fabric andthe coating comprises a silicone. After coating, the surgical articlepreferably remains porous to afford tissue ingrowth. Preferably, if theimplantable article is to be used in a sacral colpopexy procedure, theimplantable article is sized and shaped to loosely extend from thepatient's sacrum to the patient's vagina with at least some slack.

Alternatively, portions of the implantable article (e.g. the baseportion) may comprise suture bridges instead of fabric or substantiallyflat, planar structures.

In another aspect, the present invention comprises a surgical kit foruse in a procedure for addressing a pelvic floor disorder. The surgicalkit comprises a preassembled implantable article having a base portion,securement means for securing the base portion of the implantablearticle to tissue, and a surgical article for inserting the securementmeans into tissue. Preferably, the kit includes a Y-shaped article thatis sized and shaped to treat vaginal vault prolapse during a sacralcolpopexy procedure.

In the context of a surgical kit of the present invention, theimplantable article is preassembled, that is, it is substantiallycompletely constructed prior to the surgical procedure. By“substantially completely constructed”, it is contemplated that thesurgeon may still have to trim redundant portions of the implantablearticle during the surgical procedure. For example, for a small patient,some of the base portion may be trimmed from the surgical article by thesurgeon just before implantation.

The preassembled implantable article is preferably preassembled in aY-shape and is sterile packaged. In the context of a kit according tothe present invention, the implantable article may preassembled by anysuitable means including adhesives, bonding agents, tissue sealants,sutures or mechanical fasteners.

Preferably, the securement means comprises a bone anchor with associatedsutures (e.g. braided or monofilaments), self tapping screws, darts orthe like. Alternatively, the securement means may comprise suturessuitable for implantation into bone.

The surgical article may comprise a powered (e.g. battery, plug-in,compressed fluid, etc.) surgical instrument or a manual surgicalinstrument. Preferably, the surgical article comprises a motorizedsurgical driver having a shaft. Preferably, the shaft is sized andshaped to extend from the abdomen of a patient to the sacrum.Alternatively, the surgical article may comprise a needle capable ofplacing a suture in bone, or a needle suitable for placing a suture inligament or a needle suitable for placing a suture in soft tissue.

In another aspect the present invention comprises a method of making animplantable surgical article. The method comprises the steps of 1)providing a thin, first strip with first and second ends, majorsurfaces, and a length between the first and second ends; 2) providing athin, second strip with first and second ends, major surfaces, and alength between the first and second ends; the length of the second stripbeing less than that of the first strip; 3) placing a major surface ofthe first strip against a major surface of the second strip; and 4)bonding the first strip to the second strip.

Preferably, the step of bonding the first strip to the second stripincludes the step of bonding the first strip to the second strip with asilicone elastomer.

In one embodiment, the method preferably further includes the step ofproviding a fixture with a recessed portion, and the step of placing amajor surface of the first strip against a major surface of the secondstrip includes the step of placing at least a portion of the first andsecond strips in the recessed portion of the fixture. In thisembodiment, the step of bonding includes the step of bonding the portionof the first strip within the recessed portion to the portion of thesecond strip within the recessed portion. Liquid silicone is preferablyinjected into the recessed portion of the fixture.

Additional steps may be optionally incorporated in the method of thepresent invention. For example, silicone could be cured with heatingmeans and excess silicone within pores may be removed by blowingcompressed air on the article during the procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be seen asthe following description of particular embodiments progresses inconjunction with the drawings, in which:

FIG. 1 is a perspective view of one embodiment of implantable articleaccording to the present invention;

FIG. 2 is a schematic side view that illustrates a method of inserting abone anchor in the sacrum according to an embodiment of the presentinvention;

FIG. 3 is a schematic side view of the patient of FIG. 2 after theimplantable article of FIG. 1 has been implanted;

FIG. 4 is a side view of a vaginal distender for use in a surgical kitaccording to an aspect of the present invention;

FIG. 5 is a side view of another embodiment of distender according toanother aspect of the present invention;

FIG. 6 is a perspective view of another embodiment of implantablearticle according to the present invention;

FIG. 7 is perspective view of another embodiment of implantable articleaccording to the present invention;

FIG. 8 is a perspective view illustrating a step in a method of makingor preassembling the implantable article of FIG. 1;

FIG. 9 is a perspective view illustrating a step in a method of makingor preassembling the implantable article of FIG. 1;

FIG. 10 is a schematic view of another method of making an implantablearticle according to another aspect of the present invention;

FIG. 11 is a perspective view of a surgical article for use in a kitaccording to an aspect of the present invention;

FIG. 12 is a schematic view of a surgical kit assembly according to anaspect of the present invention;

FIG. 13 is a schematic side view of a patient after an alternativeembodiment of implantable article has been inserted;

FIG. 14 is a schematic view of the implantable article of FIG. 13; and

FIG. 15 is a schematic view of elements of an implantable articleaccording to a preferred embodiment of the present invention.

DETAILED DESCRIPTION

The following description is meant to be illustrative only and notlimiting. Other embodiments of this invention will be apparent to thoseof ordinary skill in the art in view of this description.

FIG. 1 illustrates an embodiment of implantable article 10 according toone aspect of the present invention. The implantable article of thepresent invention may generally be used in a variety of surgicalprocedures, preferably surgical procedures directed toward addressingurological disorders, and more preferably to surgical procedures foraddressing pelvic floor disorders such as prolapse (e.g. vaginal),enteroceles (e.g. of the uterus), rectoceles and cystoceles.Non-urological procedures such as eventration or hernia repair, andvisceral, parietal and neurological procedures are also included withinthe scope of the present invention. In a preferred embodiment, theimplantable article 10 is used in a sacral colpopexy procedure. It iscontemplated that the present invention may also be utilized inconjunction with other procedures, such as, but not limited toculposuspension, culdoplasty, procedures for addressing cystoceleprolapse, and other surgical procedures that utilize an implantablearticle.

The dimensions of the implantable article will depend upon a variety offactors including the intended surgical uses. Preferably, for a sacralcolpopexy procedure, the dimensions are at least sufficient to extendfrom the sacrum to the vaginal apex with additional size to account forthe imprecision associated with the range of human anatomy sizes and fora small amount of slack. In a preferred embodiment, the maximum width ofthe implantable article is between about 1 and 6 centimeters, theoverall length is between about 10 and 20 cm, and the thickness isbetween about 0.020 inches (0.508 mm) and 0.040 inches (1.016 mm). Morepreferably, the overall length is between about 17 cm and 17.4 cm., thewidth is about 4 cm and the thickness is between about 0.024 inches(0.61 mm) to about 0.036 inches (0.914 mm).

FIG. 1 illustrates a preferred embodiment of implantable article 10according to the present invention. The article 10 comprises a baseportion 18 and a head portion comprising a first tissue engagementportion 14 and a second tissue engagement portion 16. Each of theportions 14 and 16 extend from the base portion 18.

The implantable article 10 preferably includes separation forcedistribution means 12 for attaching at least one of the tissueengagement portions (e.g. portion 14) to the base portion 18 in afashion that distributes a force that would tend to separate the tissueengagement portion 14 from the base portion 18 over a relatively widearea, as opposed to merely a suture that would tend to concentrate sucha force at the location of the suture.

The means 12 preferably comprises any suitable material or assembly ofmaterials. Preferably the material or the assembly of materials isbiocompatible. Examples of suitable compositions include tissueadhesives, tissue sealants, biocompatible bonding agents (e.g.silicone), and biocompatible adhesives. Alternatively, RF or ultrasonicwelding or heat sealing may be used alone or in conjunction with othertechniques to create the separation force distribution means.

In a preferred embodiment, the implantable article has a plurality ofpores that afford tissue ingrowth and resist infection. Preferably, theimplantable article 10 comprises a backing that is coated. The backingmaterial may comprise one or more woven, knitted or inter-linkedfilaments or fibers that form multiple fiber junctions. Monofilament andmulti-filament embodiments are within the scope of the presentinvention. The fiber junctions may be formed via weaving, bonding,ultrasonic welding, knitting or other junction forming techniques,including combinations thereof. In addition, the size of the resultantopenings or pores of the implantable article 10 should be sufficient toallow tissue in-growth and fixation within surrounding tissue. As anexample, not intended to be limiting, the holes may comprise ellipticalor diamond shaped holes with a diagonal in the range of about 0.040inches (1.016 mm) to about 0.055 inches (1.397 mm).

The implantable article 10 may be made of a variety of materialsincluding, but not limited to, Prolene™, nylon, polypropylene, Deklene™,poly-L-lactide (PLLA), polyethylene glycol (PGA), polyester and anycombination of materials. Depending on the desired treatment, thearticle 10 or portions thereof, may be absorbable, non-absorbable and/orresorbable.

Non-synthetic structures are also included within the scope of theinvention. Other synthetic and non-synthetic materials suitable for usein the present invention include, but are not limited to, syntheticbiomaterials, allografts, homografts, heterografts, autologous tissues,materials disclosed in U.S. Provisional Applications Ser. No.60/263,472, Ser. No. 60/281,350 and Ser. No. 60/295,068 (whose contentsare fully incorporated herein by reference), synthetic materials (suchas metallics, polymerics, and plastics) and any combination of suchmaterials may also be used as an element of an implantable article ofthe present invention.

Specific examples of suitable synthetic materials for use in the presentinvention include, but are not limited to polypropylene, polyester,polyethylene, nylon, PLLA and PGA. Preferably, the material should causeminimal to no reaction with body tissues and fluids and indefinitelyretain its particular material characteristics/properties. Portions orall of the material may be resorbable if consistent with the desiredsurgical procedure.

In another embodiment, the article 10 is a flexible, polypropylenemonofilament that resists weakening or degradation when implanted withina patient. One such material is Marlex™ material. As another example,not intended to be limiting, the mesh may be woven polypropylenemonofilament, knitted with a warp tricot.

In another embodiment of the invention, the implantable article 10 orportions thereof, may have one or more substances associated therewiththrough a process such as coating. Examples of appropriate substancesinclude, without limitation, drugs, hormones, antibiotics, antimicrobialsubstances, dyes, silicone elastomers, acetal, polyurethanes, radiopaquefilaments or substances, anti-bacterial substances, chemicals or agents,including any combinations thereof. The substances may be used toenhance treatment effects, reduce the potential for implantable articleerosion or rejection by the body, enhance visualization, indicate propersling orientation, resist infection, promote healing, increase softnessor other desirable effects.

Optionally, a dye may be coated on one surface of the article 10 or aportion of the article 10 such as portion 14. The dye provides thepractitioner/surgeon with a visual indicator to aid in properlyorienting the article 10 at the target site within the patient. Asanother example, the article 10 may be coated by a process described inany of U.S. Pat. Nos. 5,624,704; 5,756,145; 5,853,745; 5,902,283 and6,162,487 (the entire contents of which are hereby incorporated byreference).

Referring to FIG. 1, the base portion 18 is preferably, a thin, flexiblestructure that has a length and a width along first and secondorthogonal axes that are much greater than the thickness of the baseportion 18 (the thickness being measured along a third axis that isperpendicular to the first and second axes). The tissue engagementportions 14 and 16 are flexible and can extend along the third axis(i.e. the axis that is perpendicular to the first and second orthogonalaxes) so that substantial structure may extend in three dimensions, asopposed to a flat, rectangular, prior art implant that only providessubstantial structure in two dimensions. This allows the implantablearticle 10 to more readily conform to irregular, non-planar tissuesurfaces such as the apex of the vagina.

FIGS. 2 and 3 schematically illustrate a surgical procedure thatutilizes implantable article 10. FIG. 2 illustrates a powered surgicaldevice 40 placing two bone screws 44 with attached sutures into thesacrum 30 of the patient 20. The vagina 26, sacrum 30, urethra 24,pelvic bone 22, vaginal cuff 28 and rectum 29 are shown schematicallyand should not be interpreted as being shown to scale or for anatomicalprecision.

Preferably, sacral segment three 38 is selected for the bone screws withattached sutures. The precise, final location of the implantable article10 in the physiological environment will depend on a variety of factorsincluding the particular surgical procedure(s) performed, the particularanatomy of the patient (e.g. the location of veins, nerves andarteries), and any preconditions of the patient such as scar tissue orprevious surgeries. For a sacral colpopexy, sacral segment three 38 ispreferred but other attachment locations are contemplated. Portions 14and 16 of the implantable article 10 are sutured to the vagina cuff 28and the base portion 18 of implantable article 10 is tied to the bonescrews 44 by the sutures attached to the bone screws 44.

The implantable article 10 may optionally have a feature that assiststhe surgeon in placing the implantable article 10 in a therapeuticallyeffective anatomical position. For example, it may be desirable toattach portion 14 of the implantable article 10 to the posterior side ofthe vaginal apex and the portion 16 to the anterior side of the vaginalapex. For this feature, a variety of means may be used. For example,portion 14 may be a different color than portion 16. Alternatively,indicia may be printed on portion 14 or 16 that indicates properorientation.

In another aspect, the present invention comprises a surgical kit foruse in a procedure for addressing a pelvic floor disorder such as asacral colpopexy. Referring to FIG. 12, the surgical kit 90 comprises apreassembled implantable article (shown as being preassembled andpackaged in a sterile package 94), securement means for securing thebase portion of the implantable article to tissue (shown as withinsterile package 95), and a surgical article for inserting the securementmeans into tissue (shown in sterile package 92).

The preassembled implantable article 94 preferably comprises animplantable article similar to that shown in FIG. 1 that includes aseparation force distribution means 12 (e.g. a bond). It is noted that,in the context of the kit of the present invention, the preassembledimplantable article 94 may comprise any implantable article with two ormore elements preconnected together to form the implantable article. Thespecific means of connecting the two or more elements may comprise anysuitable means including adhesives, bonding agents, mechanical fasteners(e.g. a medical grade plastic clip) or even sutures. Having apreassembled implantable article in a kit that is ready for use in asurgery saves valuable surgeon time and potentially reduces operationtime.

The securement means 95 preferably comprises bone anchors. The boneanchors may comprise tacks, screws, bone sutures, staples, fasteners,pins, nails, headless screws, darts, or any suitable means foranchoring. More preferably, the bone anchors comprise self-tapping bonescrews. More preferably, each bone screw has a suture attached thereto(e.g. a polypropylene monofilament). The sutures may be braided or amonofilament. The bone anchors may comprise those disclosed in any ofU.S. Pat. Nos. 5,520,700, 5,674,247; 5,807,403; 5,873,891; 5,972,000;and/or U.S. patent application Ser. No. 09/476,682, filed Dec. 30, 1999(the entire contents of which are herein incorporated by reference). Asan example, not intended to be limiting, the securement means maycomprise medical grade titanium bone anchors with associated sutures.The sutures may comprise monofilament polypropylene or braided polyesteror braided polyester coated with polytetrafluoroethylene (Teflon, PTFE),such as those generally available from Genzyme/Deknatel of Fall River,Mass.

Alternatively, the securement means in the kit may comprise tissueadhesive, tissue sealant, sutures (e.g. for implantation into bone),ligament sutures, bone tacks and other suitable elements.

The kit 90 also includes a sterile packaged surgical article 92 for usewith the securement means. The surgical article (e.g. 40) within sterilepackage 92 is used to apply the securement means 95 during the surgicalprocedure. The surgical article may comprise any suitable surgicaldevice. For example, the article may comprise a tissue adhesivedispenser, a tissue sealant dispenser or any of those articles describedin U.S. patent application Ser. No. 09/476,682, filed Dec. 30, 1999;and/or U.S. Pat. Nos. 4,312,337; 4,941,466; 5,330,479; and 5,509,918,and/or PCT International application no. PCT/IL 00/00320, filed Apr. 6,2000; and/or PCT international publication nos. WO 97/47246 and 00/74578(the entire contents of which are incorporated by reference).

FIG. 11 illustrates a preferred surgical article 40 for implanting aself tapping bone screw 44 having a suture 43 attached thereto. Thesurgical article 40 comprises a motorized driver having a shaft 41. Theshaft 41 is preferably sized and shaped to extend from the abdomen of apatient to the sacrum. For example, the shaft may be approximately 28 cmin length or longer.

The surgical article 40 may be constructed in accordance with U.S. Pat.No. 5,520,700; and/or U.S. patent application Ser. Nos. 09/476,682,and/or 09/776,545, filed Feb. 2, 2001 (the entire contents of each ofwhich is herein incorporated by reference). The surgical article 40rotates the bone screw 44 to implant the bone screw 44 and attachedsuture 43.

The precise shape of the implantable article for the kit 90 will dependon a variety of factors including the desired therapeutic effect, theintended physiological environment for the implantable article, thesurgical procedure and convenience. If the kit is used to treat vaginalprolapse in a sacral colpopexy procedure, the implantable article ispreferably preassembled in a Y-shape. The article is preferably sizedand shaped to loosely extend from the patient's sacrum to the patient'svagina with at least some slack.

Alternatively, instead of powered surgical driver 40, the surgicalarticle within package 92 may comprise a needle capable of placing asuture in bone, soft tissue or in a ligament.

The surgical kit 90 may include a variety of optional elements. Forexample, the kit may include a vaginal distender in sterile package 97.FIG. 4 illustrates a preferred embodiment of vaginal distender 50.Preferably, the vaginal distender is sized and shaped similar to adistender used in conjunction with a circular stapler in bowel surgeryto create an end-to-end anastomosis.

The vaginal distender includes a handle portion 52 and an end portion 54with a rounded, bulbous shape. The end portion is preferably constructedfrom material that allows a suture carrying needle to be driven throughan implantable article, through vaginal tissue and against the endportion 54 so that the end portion 54 acts as an anvil-like structure.As an example, not intended to be limiting, the maximum diameter of theend portion 54 may be about 1.25 inches (alternatively, e.g., 31 mm indiameter) and the handle portion may have a maximum diameter of about0.625 inches. The distender assists the surgeon in attaching theimplantable article circumferentially to the irregular shaped vaginalcuff, thereby reducing the potential for point stresses in the vagina.

FIG. 5 illustrates another embodiment of optional distender 50Aaccording to the present invention. The distender 50A may be utilized toattached a portion of an implantable article 10′ to the vagina 26 of apatient. This distender 50A has the potential to reduce the invasivenessof the procedure. Alternatively, the distender 50A may be utilized todirectly connect the vagina 26 to the sacrum of the patient. In thisembodiment, the article 10 is not used. Instead, the vagina is stapleddirectly to the sacrum. Optionally, this procedure may be monitored orperformed laparoscopically, at least in part.

The distender 50A includes staples 62, drive member 54′ and stapleforming means (not shown). The staple forming means may comprise ananvil as described, for example, in U.S. Pat. Nos. 3,873,016; 4,202,480;4,317,535 and 4,527,725 (the entire contents of which are hereinincorporated by reference). To operate the distender 50A, the vagina 26is placed between the implantable article 10′ and the end portion 54A.The drive member 54′ may be moved in the direction of the arrow in FIG.5. The drive member 54′ drives the staples 62 against anvils, throughvaginal tissue 26, through ends 14′ and 16′ of implantable member 10′and forms the staples into the “B” shapes shown in FIG. 5.

The kit 90 may be in the form of a plurality of prepackaged articles.Alternatively, the elements of the kit may be provided in a singlepackage.

The elements of the kit 90 are preferably supplied in a sterile package.The elements may be sterilized by any suitable sterilization means,including steam sterilization, ethylene oxide sterilization, plasmasterilization, hydrogen peroxide vapor sterilization, peracetic acidsterilization, IR sterilization or the like.

While implantable article 10 is preferably Y-shaped for addressingvaginal prolapse during a sacral colpopexy in females, other shapes arealso contemplated. Depending on the treatment addressed (e.g. to addressa rectocele, enterocele or prolapse) the implantable article may be anyof a wide variety of shapes. FIG. 6 illustrates another embodiment ofimplantable article according to the present invention. The implantablearticle shown in that Figure includes a base portion 18A, and two tissueengagement portions 14A and 16A. Tissue engagement portion 14A has alength less than that of tissue engagement portion 16A.

The implantable article shown in FIG. 6 includes a separation forcedistribution means in the form of an acetal clip 11. The acetal clip maybe attached to the implantable article before or during surgery. Theacetal clip may be used to adjust the tension of the implantablearticle. In one embodiment, the acetal clip 11 may be insert moldedaround the sling material providing an attachment point for sutures tobe attached.

While the base portion (e.g. 18A) is illustrated as a flat strip, it isalso contemplated that the base portion could comprise one or more(preferably two) sutures (e.g. 43 in FIG. 11) extending from the bonescrews (e.g. 44 in FIG. 3) to one or more sutures holes in the acetalclip 11. The sutures 43 could be cut and tied to adjust the tension ofthe implantable article. It is believed that the tension of animplantable article with sutures 43 serving as a base portion may bemore readily adjustable postoperatively than an implant with a baseportion strip (e.g. 18A).

FIG. 7 illustrates another embodiment of implantable article accordingto the present invention. The implantable article includes a baseportion 70 with sutures hole 72 and tissue engagement portions 14B and16B.

The implantable articles of the present invention may also include otheroptional features. FIGS. 13 and 14 illustrate another embodiment ofimplantable article 10D. The implantable article 10D includes tissueengagement portions 14D and 16D. Instead of a fabric base portion, thearticle 10D includes at least one (and preferably two) sutures S whichform a bridge to anatomical structure such as bone, ligament or softtissue.

FIG. 13 illustrates the article 10D implanted in the body. The vagina26, sacrum 30, urethra 24, pelvic bone 22, vaginal cuff 28 and rectum 29are again shown schematically and should not be interpreted as beingshown to scale or for anatomical precision. Preferably, the suturesbridge to bone screws 44 implanted in the sacrum 30 (preferably sacralsegment three 38). Alternatively, the sutures may anchor to ligament orsoft tissue.

FIG. 14 illustrates a preferred embodiment of implantable article 10D.The implantable article includes a clip 11D. The implantable article 10Dpreferably includes means for taking up and/or providing suture S lengthto adjust the tension of the article 10D. The means may affordadjustment of the tension of implantable article during the surgicalprocedure or after the surgical procedure. The article 10D may alsoinclude a means for preventing excessive tension from being applied tothe suture of a bone anchor.

As shown in FIG. 14, the means may comprise one or more rotatable wheelsW. The wheels W may be rotated in the direction of the arrows to tightenthe tension in the sutures S (and correspondingly, the tension inimplantable article 10D). Rotation of the wheels W in the oppositedirection loosens tension. The implantable article may also beconstructed so that the tension of the article may only be tightened.Alternatively, the implantable article may be constructed so that thetension of the article may only be loosened. The wheels W preferablyinclude an indexing mechanism (not shown) for holding the wheel in aparticular position.

FIG. 15 illustrates a preferred embodiment. For example, the article 10Dmay include a ratchet wheel RW having a plurality of ratchet teeth T,pawl P and biasing spring B. The pawl P would allow rotation of thewheel RW in one direction (e.g. to tighten the implantable article 10D),but not in the other direction. The pawl also retains the wheel in aplace until the wheel RW is rotated. An incision in the vagina may bemade to gain access to the wheel RW to rotate it with a surgical toolsimilar to a screwdriver. A slot on the wheel RW may be adapted toengage the screwdriver to afford rotation of the wheel RW.

In cases of vaginal shortening due to scaring or previous surgeries, theability to tension the device post operatively may afford gradualrestoration of vaginal length. If the ratchet wheel is constructed froma radioopaque material and from a material (e.g. metal) that may bemoved by virtue of a remote force (e.g. a magnetic field), then thearticle 10D may afford the ability to adjust the tension without asubsequent surgical incision. After the surgical procedure, a surgicaldevice capable of delivering a remote force (e.g. one similar in shapeto the vaginal distender) may be inserted in the vagina and used torotate the ratchet wheel W without an incision. The actual location ofthe ratchet wheel may be monitored by virtue of the radioopaque natureof the wheel.

In another embodiment, a remotely actuatable mini-motor may beincorporated in the implantable article to afford post operativeadjustment of the implant. For example, the motor could comprise aminiature brushless motor generally available from Micro Mo ElectronicsInc., of Clearwater, Fla.

Other alternatives for attachment of sutures include the folding of theimplantable article over a small diameter acetal rod and silicone insertmolding the rod into the fold of the implantable article. Alternativesto insert molding include a folding acetal clip that clips on to apreferred sling material in such a manner as to provide places forattachment of sutures. The acetal clip may have holes for sutures orprovide a yoke for suture attachment. This affords a convenient and easymethod of making a Y-shaped implantable article without sewing orsuturing. It also creates a secure place for suture fixation andpossible future adjustment. Even without an adjustment mechanismincorporated into the attachment point, future tensioning or looseningis facilitated as implantable fabric does not extend a great distance(e.g. to the sacrum for a sacral colpopexy) and this allows forreplacement of fixation sutures without removal of a large amount ofingrown tissue.

In another embodiment of implantable article according to the presentinvention, the adjustment mechanism may be incorporated to tension orloosen the implantable article between the vaginal cuff and the sacrumin the immediate postoperative period. Access to the adjustment meansmay be achieved through an abdominal incision, laparoscopically, orpreferably via a minimally invasive vaginal incision. A remotelyactuatable mechanism (e.g. a magnet) may also be employed. This could beaccomplished with a ratchet/pawl mechanism similar to that shown in FIG.15.

In another embodiment of the invention, one or more substances may beassociated with the implantable article 10 by, for example, a coatingprocess. The substances may be used to enhance treatment effects,indicate proper orientation, enhance visibility, encourage tissueingrowth, resist infection or other effects. For example, theimplantable article 10 may be dyed a contrasting color (e.g. blue)relative to its physiological environment. The contrasting color of theimplantable article 10 provides the surgeon with a visual indicator thatcan be used to confirm proper orientation. In addition to coatingsubstances, other components including, without limitation, tags, labelsor indicia may also be used to indicate proper sling orientation orenhance visibility/identification.

EXAMPLES

A variety of materials and construction techniques may be used inconjunction with the present invention. As an example, not intended tobe limiting, the material may comprise any of the materials described inU.S. Provisional Patent Application No. 60/230,647, filed Sep. 7, 2000(the entire contents of which are herein incorporated by reference).

Example 1 Material and Method

The implantable article 10 is preferably constructed from a base orbacking material, e.g. a tightly woven polyester mesh having a pluralityof pores. The polyester mesh is ultimately coated with a siliconedispersion. The base material may be a Rashel knit mesh made from 150dernier polyester yarn. In an uncoated state, the thickness may bebetween about 0.01 inches and about 0.04 inches, preferably about 0.020inches (0.508 mm). The mesh has a hole size of approximately 1/32″ (25.4mm) and a weight of approximately 4.7 oz/yard (133.25 grams/0.914 m)constructed from polyester or polypropylene. Preferably, the poredensity is between 50 and 400 pores/square inch, more preferably about240 pores per square inch. After coating, the size of the holes or poresis preferably in the range of about 0.040 inches (1.016 mm) to about0.055 inches (1.397 mm).

The polyester material is coated with a silicone material (e.g. NuSilMED 6820, available from NuSil of Carpinteria, Calif.) by a dip coatingprocess. The silicone dispersion results from mixing equal parts (e.g.100 g each) of Medium 6820 with about 5 parts (e.g. 500 g) solvent suchas Xylene. Stirring on a stir plate in a fume hood can mix thedispersion. Mixing should be performed for a minimum of 20 minutes withthe container covered to minimize evaporation.

A container or reservoir (e.g. pan) is filled with the siliconedispersion for immersion of the mesh material. The pan is covered toresist evaporation.

The mesh is placed in the dispersion mix and is held flat by use of, forexample, 6 inch (15.24 cm) embroidery hoops. When using embroideryhoops, the mesh material should be pulled through the edges of the hoopuntil the mesh material is taut, flat and constrained along most if notall of the peripheral edge of the mesh material. Care is taken not toinordinately stretch the material as this may result in distortion ofthe holes of the mesh material or in uneven coating of the meshmaterial. The mesh material should be trimmed to be sized closely to thedimensions of the hoop so as to minimize overlap. The hoop containingthe mesh material is placed into the reservoir containing the siliconedispersion for about 15 seconds, or more and then removed.

In another embodiment of method, the material can be held in tension atopposite ends of the sheet prior to applying the coating. In yet anotherembodiment, a roll of the mesh may be continuous fed into a reservoirand then further processed (e.g. heated, and/or air blown as describedbelow) in web form.

Excess silicone dispersion is removed by allowing the silicone to dripoff of the mesh material as the hoop is placed flat over the pan forabout 1-5 minutes.

The coatings within the holes of the material are cleared. This may beaccomplished by using a foot controlled air nozzle with an air settingof approximately 55-psi and 600 pulses per minute. Using the air nozzle,the coated mesh material can be continuously sprayed to free theopenings until there are minimal or no holes filled with siliconedispersion. Alternatively, the spraying can be performed intermittently.The coated material is rested, air-sprayed side up, for approximately5-15 minutes.

The steps above (starting with filling a reservoir) may be repeated withthe exception that the second side of the mesh material is now airsprayed to provide a uniform distribution of the silicone coating overall surfaces of the material.

The spraying ensures that the holes or pores of the mesh are not filledor closed with silicone. Preferably, the implantable article of thepresent invention includes open pores or holes to encourage tissueingrowth and to resist infection.

Preferably, the above steps are repeated until the material has at leasttwo coatings of silicone dispersion. More preferably, the process isrepeated six times.

The silicone coating is then preferably heated to set the siliconedispersion. This may be accomplished by hanging the hoops holding thematerial in an oven that is set at 160 degrees Celsius (+/−10 degrees)for about 20 minutes. The material is then removed from the oven andallowed to cool. The material is then cut from the hoop. Optionally, ananti-microbial substance or medicament may be impregnated into thesilicone elastomer during this process or during a subsequent process.

Preferably, the material is configured in a long narrow elongated piece.The width is approximately the same width as the implantable article.The edges of the material along the length of the material are coatedwith silicone by the above process. When an elongated material is used,all that is required to obtain a sling suitable for use in a patient isto cut the elongated material through its width at the desired length ofthe implantable article. This yields an implantable article that has theedges along the longitudinal side of the material completely coated withsilicone (with the integrity of the coating along the longitudinal sideintact). Optionally, a material cut along an end may be redipped insilicone to coat a cut edge.

The thickness of the final coated material was between about 0.024 andabout 0.036 inches.

Alternatively, the material may be supplied according to the teachingsof Cabak et al., U.S. patent No. 60/230,647, (U.S. Patent Applicationassigned to the assignee of the present case), filed on Aug. 24, 2001(on the even date of the present application) (the entire contents ofwhich are herein incorporated by reference).

Example 2 Construction

Referring to FIG. 8, the silicone coated material of Example 1 was cutinto two rectangular components each having a width of about 38 to about42 mm. The larger component 16C had a length of about 147.3 to about152.4 mm. The smaller component 14C had a length between about 43 andabout 45 mm.

The larger component 16C was placed on a flat fixture and the smallercomponent 14C was placed on top of it. The edges are even andsubstantially parallel as shown in FIG. 8.

A dispenser having two separate reservoirs, a static mixer, and nozzle80 is positioned at the edge of the smaller component 14C as shown inFIG. 9. The components of the liquid silicone elastomer (e.g. MED-4840LSR elastomer, generally available from NuSil) are loaded into thereservoirs.

The elastomer is placed at the edge of the short portion 14C so that itflows through the pores and provides a layer of elastomer at the top andbottom of the bond. Preferably, at least two full rows of pores arecompletely filled with elastomer.

The assembly may be placed in an oven at 110 degrees Celsius for 6minutes minimum. The finished assembly exhibited excellent resistant topull apart loading (19.1 lbs.) and cyclical load wear.

Example 3

FIG. 10 illustrates an example similar to that of Example 2, except thata recessed fixture 77 is used. The nozzle 75 may be used to pressagainst the edge of the short portion 14C of the implant. This processmay be manual or automated in whole or in part.

This example comprises a method of making an implantable surgicalarticle comprising the steps of (1) providing a thin, first strip withfirst and second ends, major surfaces, and a length between the firstand second ends; (2) providing a thin, second strip with first andsecond ends, major surfaces, and a length between the first and secondends; the length of the second strip being less than that of the firststrip; (3) placing a major surface of the first strip against a majorsurface of the second strip; and (4) bonding the first strip to thesecond strip.

Preferably, the step of bonding the first strip to the second stripincludes the step of bonding the first strip to the second strip with asilicone elastomer.

Also preferably, the process includes the step of providing a fixturewith a recessed portion. The step of placing a major surface of thefirst strip against a major surface of the second strip preferablyincludes the step of placing at least a portion of the first and secondstrips in the recessed portion of the fixture; and the step of bondingincludes the step of bonding the portion of the first strip within therecessed portion to the portion of the second strip within the recessedportion.

Surgical Procedures

Many surgical methods are contemplated herein. Although the methods ofuse as disclosed herein generally relate to female disorders andtreatments/procedures, male disorders and treatments/procedures are alsoincluded within the scope of the present invention.

Abdominal Incision/Bone Anchors

The present invention may be utilized to address vaginal vault prolapse.The patient is placed in the lithotomy position using padded lower thighand calf support, and drapes are applied preferably using both leggingsand laparotomy sheet. A kit having bone anchor screws and other elementsdescribed above may be used to perform a sacral colpopexy.

The anterior abdomen, vagina and bowel are thoroughly prepped and astandard Foley catheter is inserted into the urinary bladder. Thesterile manipulating vaginal distender (e.g. see FIG. 4) is inserted.

The abdomen is opened via a midline or Pfannenstiel incision and aself-retaining ring retractor is positioned. The sigmoid colon is heldto the patient's left. A midline incision is made in the posteriorperitoneum overlying the midline of the sacrum after identification ofthe right ureter. This incision is made with electrocautery and carriedthrough the retroperitoneal fat tissue to the periosteum of the sacrum.

The implantable article of the present invention is secured. It ispreferably preassembled, in the shape shown in FIG. 1 and measuring 17cm in overall length, 4 cm in width (with the minor leg portions havinga length of about 6 cm).

After the posterior parietal peritoneum overlaying the sacral promontoryis opened (e.g. longitudinally), the periosteum of the sacrum isselected for placement of bone anchor screws with attached sutures.Preferably sacral segment three (S₃) is selected. Optionally, othersacral segments may be selected according to a variety of factors suchas surgeon experience level, the particular anatomy structure of thepatient, and tissue condition.

Caution is exercised to avoid disruption of the presacral veins (e.g.the middle sacral vein traversing over the promontory) and any proximatevessels or nerves. The bone anchor screws may be placed using a poweredinserter such as the Straight-In Inserter, generally available fromAmerican Medical Systems, Inc. of Minnetonka Minn. The screws areinitially loaded into the inserter device. The tip of the loaded screwis placed perpendicular to the bone. The surgeon presses the inserter'soperating button until the screw is completely inserted. The operatingbutton is released and the inserter is removed. Preferably, the screwsare placed 1-1.5 cm apart vertically in the midline or horizontally oneither side of the sacral segment, depending on the pattern and locationof the adjacent veins, nerves and vessels. The sutures from the boneanchors may then be tagged and attention turns to preparation of thevaginal apex.

With one hand manipulating the vaginal distender, the vaginal apex isfreed of attached bladder using sharp and blunt dissection for adistance of about 3-4 cm. It is rarely necessary to dissect tissue fromthe posterior vaginal apex unless bowel is adherent in an enterocele.

The anterior and posterior segments of the implantable article aresecured to the vaginal apex using about 6 to 10 uninterruptednonabsorbable sutures (e.g. spaced 1.5 cm apart), fore and aft, drivingthe suture needle against the distender to preferably produce afull-thickness graft of the vaginal apex. Once the implantable articleis secured to the vaginal apex, the vaginal distender can be removed anddiscarded. Alternatively, a tissue adhesive may be used in conjunctionwith the suturing or in the place of the suturing.

The sutures of the bone anchors are used to tie the base of theimplantable article to the bone anchors. Preferably, tension should beavoided while fixing the base of the implantable article to the boneanchors. For example, about 1 cm slack may be provided. The implantablearticle preferably provides a hammock of support, so that any increasein intra-abdominal pressure will be transmitted to the implantablearticle, flattening the vaginal apex against the sacrum. Redundantportions of the implantable article may be trimmed andreperitonealization performed with interrupted sutures placed so as tocompletely cover the implantable article.

Optionally, retropubic urethropexy may be performed (unless previouslyperformed), as elevation of the vaginal apex tends to flatten theposterior urethrovesical angle. These steps may help avoid genuinestress urinary incontinence.

After thorough irrigation of the operative site, the abdomen may beclosed.

Bone Sutures

This procedure is similar to the abdominal incision process describedabove except that the kit need not include bone screws or a surgicaldevice for inserting bone screws. Instead, after the anterior surface ofthe sacral promontory is visualized, two or three sutures (e.g.polyester or polypropylene sutures suitable for use in bone) may beplaced in the periosteum over the sacral promontory using, for example aM0-6 or M-07 needle.

The sacral promontory sutures are then used to secure the implantablearticle to the promontory. Tension in the implantable article is avoidedand any excessive length of the implantable article is trimmed.

Laparoscopic Technique

The abdomen is insufflated using a conventional pneumoneedle. Aplurality of cannula ports are opened with safety trocars at locationsapt to avoid sensitive structures such as the inferior epigastricartery, the external iliac artery, the superficial epigastric artery,and the superficial circumflex iliac artery. Five and ten millimeterports are preferred.

After the ports are placed, the peritoneum is dissected off the vaginalapex to delineate the rectovaginal fascia. Anterior dissection isperformed. The vaginal distender is used to identify the vaginal apex.

The peritoneum overlying the sacral promontory is incised longitudinallyand extended to the cul-de-sac. A laparoscopic dissector orhydrodissection may be used to expose the periosteum of the sacralpromontory.

The implantable material is introduced through a port (preferably a10/12 mm port). The implantable article may be sutured (e.g. with no. 0non-absorbable sutures) to the anterior and posterior portions of thevaginal apex (3 rows each) with a laparoscopic suturing device. Thestitches are placed through the entire thickness of the vaginal wall.

The implantable article is then attached to the sacrum or the ligamentof the sacrum or the anterior sacral fascia (longitudinal ligament). Twono. 0 or 2-0 non-absorbable sutures may be used for this purpose.Alternatively, titanium tacks, bone anchors, bone screws or herniastaples may be used to attach the base of the implantable article. Anyexcess portion of the implantable article may be trimmed.

A laparoscopic compatible surgical device may be used to place the boneanchors (e.g. screws). For example, a manual screw driver or a poweredscrew driver that is sized and shaped to fit in the cannula of a trocarmay be utilized for this purpose.

The peritoneum is reapproximated over the implantable article (e.g. withno. 2-0 polyglactine sutures). The ports are removed and the incisionsclosed.

Transvaginal Approach

A transvaginal suspension is described in Nichols D H: SacrospinousFixation For Massive Eversion of the Vagina, AM J. Obstet Gynecol 1982;142:901-904 (the entire contents of which are herein incorporated byreference). Essentially, a vaginal incision is made and the vaginalvault is suspended from the sacrospinal ligament. The Nichols techniquemay be modified by using an implantable article according to the presentinvention. Preferably, a preassembled, Y-shaped implantable article asdescribed above may be used.

No Implant

As discussed above, the distender 50A of FIG. 5 may be utilized to tackthe vagina directly to tissue or bone (e.g. the sacrum).

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. An implantable surgical article comprising: a thin, substantiallyflat major strip having proximal and distal ends, and a length and awidth along first and second orthogonal axes; a thin, substantially flatminor strip having a length less than that of the major strip, and apair of ends; the minor strip being bonded to the major strip along anend of the minor portion with a flowable bonding agent such that asubstantial portion of the minor strip can extend along an axis that isperpendicular to both the first and second axes; the location of thebond is selected such that a portion of the major strip near its distalend and the minor strip may be sutured to a vaginal cuff of a patient;and, the distance between the proximal end of the major strip and thebond is at least sufficient to extend from the patient's sacrospinousligament to the patient's vaginal cuff.
 2. A surgical article accordingto claim 1 wherein the major and minor strips each have a perimeter withsubstantially straight edges, and the straight edges of the major andminor strips are substantially aligned to provide a surgical articlewith a substantially constant width.
 3. A surgical article according toclaim 1 wherein the minor strip has a distal end and the distal ends ofthe major and minor strips are substantially aligned.
 4. A surgicalarticle according to claim 1 wherein the major and minor strips comprisea backing with a coating.
 5. An implantable surgical article fortreating a pelvic floor disorder, the article comprising: a baseportion; a head portion comprising two tissue engagement portionsextending from the base portion; and, a separation force distributionmeans for attaching at least one of the tissue engagement portions tothe base portion in a fashion that distributes a force that would tendto separate a tissue engagement portion from the base portion across anarea greater than that occupied by a suture; the article being sized andshaped to extend from the patient's sacrospinous ligament to thepatient's vagina; and wherein the separation force distribution means isselected from a group consisting of a bonding composition, an ultrasonicweld, a mechanical fastener, and a polymeric clip.
 6. A surgical articleaccording to claim 5 wherein the base portion comprises at least onesuture and the surgical article further comprises means for adjustingthe tension of the implantable article.
 7. A surgical article accordingto claim 5 wherein the base portion comprises a major strip, and thesurgical article further comprises adjustment means for adjusting thetension of the surgical article, the adjustment means comprising amovable wheel for taking up length of the major strip or providing alength of major strip, and means for indexing the wheel in differentpositions to tighten and/or relax the tension of the surgical article.8. A surgical kit for use in a procedure addressing a pelvic floordisorder, the surgical kit comprising: a preassembled implantablearticle of claim 1, securement means for securing the base portion ofthe implantable article to tissue, and a surgical article for insertingthe at least one soft tissue anchor into tissue.
 9. A surgical kitaccording to claim 8 wherein the implantable article is preassembled ina Y-shape that is sterile packaged.
 10. A surgical kit for use in aprocedure addressing a pelvic floor disorder, the surgical kitcomprising: a preassembled implantable article of claim 5, securementmeans for securing the base portion of the implantable article totissue, and a surgical article for inserting the at least one softtissue anchor into tissue.
 11. A surgical kit according to claim 10wherein the implantable article is preassembled in a Y-shape that issterile packaged.
 12. A method of implanting an implantable article inaddressing a pelvic floor disorder, the method comprising the steps of:providing a preassembled implantable article of claim 1, and installingthe implantable article to treat pelvic floor disorder, by securing theimplantable article to tissue.
 13. A method according to claim 12wherein the implantable article is secured to the sacrospinous ligament.14. A method according to claim 12 wherein the implantable article issecured using at least one suture.
 15. A method of implanting animplantable article in addressing a pelvic floor disorder, the methodcomprising the steps of: providing a preassembled implantable article ofclaim 5, and installing the implantable article to treat pelvic floordisorder, by securing the implantable article to tissue.
 16. A methodaccording to claim 15 wherein the implantable article is secured to thesacrospinous ligament.
 17. A method according to claim 15 wherein theimplantable article is secured using at least one suture.
 18. A methodaccording to claim 12 wherein the implantable article is installedtransabdominally or transvaginally.
 19. A method according to claim 15wherein the implantable article is installed transabdominally ortransvaginally.